Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611, United States
NCT Number: NCT02595463
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.
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Notify Me4 year–10 year
All sexes
Interventional
Phase 2 / Phase 3
Chicago, Illinois, 60611, United States
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.
Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
Other names: Xylocaine, Lidocaine Hydrochloride
Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.
Other names: Placebo
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals.
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals.
Time frame: Every day, up to 7 days postoperatively
Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain.
Time frame: Every day, up to 7 days postoperatively
Parents will keep a journal of all pain medication given to their children to treat pain.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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